COVID-19 Vaccination Playbook STATE OF LOUISIANA Louisiana Department of Health Office of Public Health OCTOBER 16, 2020 | VERSION 01 STATE OF LOUISIANA COVID-19 VACCINATION PLAYBOOK Table of Contents Record of Changes ................................................................................................................................... 2 Introduction ............................................................................................................................................ 3 Executive Summary ................................................................................................................................. 4 Section 1: COVID-19 Vaccination Preparedness Planning ......................................................................... 7 Section 2: COVID-19 Organizational Structure and Partner Involvement ................................................ 13 Section 3: Phased Approach to COVID-19 Vaccination ........................................................................... 23 Section 4: Critical Populations ............................................................................................................... 28 Section 5: COVID-19 Provider Recruitment and Enrollment ................................................................... 40 Section 6: COVID-19 Vaccine Administration Capacity ........................................................................... 45 Section 7: COVID-19 Vaccine Allocation, Ordering, Distribution, and Inventory Management ................ 50 Section 8: COVID-19 Vaccine Storage and Handling ............................................................................... 52 Section 9: COVID-19 Vaccine Administration Documentation and Reporting.......................................... 55 Section 10: COVID-19 Vaccination Second-Dose Reminders ................................................................... 57 Section 11: COVID-19 Requirements for IISs or Other External Systems ................................................. 58 Section 12: COVID-19 Vaccination Program Communication .................................................................. 61 Section 13: Regulatory Considerations for COVID-19 Vaccination .......................................................... 66 Section 14: COVID-19 Vaccine Safety Monitoring ................................................................................... 68 Section 15: COVID-19 Vaccination Program Monitoring ......................................................................... 70 Appendix 1: LDH OPH Organizational Chart ........................................................................................... 76 Appendix 2: OPH Regional Map for the State of Louisiana ..................................................................... 77 Appendix 3: Legal Authorities and References ....................................................................................... 78 Appendix 4: Vaccine Action Collaborative Work Group Charters and Members ..................................... 82 Appendix 5: Overviews of Exercises Referenced in Section 1 ................................................................. 89 Appendix 6: Acronyms, Definitions and Terms ....................................................................................... 92 Appendix 7: Navigators.......................................................................................................................... 96 Appendix 8: Louisiana’s Comprehensive Point of Dispensing Plan for COVID-19 .................................... 97 Appendix 9: Louisiana’s Plan to Securely Order, Distribute, Receive, Store and Transport COVID-19 Vaccine................................................................................................................................................ 108 Appendix 10: Louisiana’s COVID-19 Vaccine Security Plan.................................................................... 120 1 | P a g e STATE OF LOUISIANA COVID-19 VACCINATION PLAYBOOK Record of Changes Date of original version: October 16, 2020 Date Change Date of Description of Change Name of Reviewed Number Change Author 2 | P a g e STATE OF LOUISIANA COVID-19 VACCINATION PLAYBOOK Introduction The State of Louisiana COVID-19 Vaccination Playbook provides a framework for the jurisdiction’s COVID-19 vaccination response. This planning builds on a number of well-established emergency operation plans of the Governor’s Office of Homeland Security and Emergency Preparedness, Parish Office of Homeland Security and Emergency Preparedness, the Louisiana Department of Health Office of Public Health. Past experiences involving the distribution and administration of vaccines, annual mass vaccination exercises of plans were used to influence this document. The security of systems, locations and transport has been assessed and will continue to develop to the current situation. The State of Louisiana COVID-19 Vaccination Playbook follows the 15 main planning sections of the CDC COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, September 16, 2020 Version 1.0. This Playbook is a living document that will evolve as knowledge about the COVID-19 pandemic and the COVID-19 vaccines develops. Louisiana will evaluate processes and procedures, sharing best practices and lessons learned throughout COVID-19 vaccination response. 3 | P a g e STATE OF LOUISIANA COVID-19 VACCINATION PLAYBOOK Executive Summary Louisiana has an established organizational structure and planning process to operationalize the COVID- 19 vaccine response. Clear roles and responsibilities were established along with a commitment of collaboration by public and private sector partners. Existing infrastructure, processes and procedures will be used to monitor performance targets, resources, activities, procurement and expenses. Evaluation and improvement will be ongoing throughout the response to identify best practices and share lessons learned. In February 2020, the Louisiana Department of Health (LDH) Office of Public Health (OPH) updated its Pandemic Influenza and Severe Viral Respiratory Pathogen Plan. A COVID-19 vaccine planning team with representatives from multiple state agencies formed in April 2020. The OPH established a formal Vaccine Action Collaborative (VAC) that includes a wide representation of professionals from both public and private sectors, to coordinate and update planning and response efforts for the allocation, distribution and dispensing of COVID-19 vaccines in July 2020. The VAC established work groups for the response effort: Prioritization and Allocation; Planning, Logistics and Operations; and Communications and Outreach. The collective work of the VAC and its work groups are represented in planning and allocation tools. This Playbook builds upon a number of existing plans related to public health emergencies. Past experiences involving the distribution and administration of vaccines were used to influence this planning document. The security of systems, locations and transport has been assessed and will continue to develop. Health equity is incorporated in every step of planning. Pharmacy engagement and Closed Point of Dispensing (POD) planning will be the framework for the initial phase of the COVID-19 vaccine response. LDH OPH will follow the Advisory Committee on Immunization Practices (ACIP) and CDC recommendations for the use of a safe and effective COVID-19 vaccine and guidance for priority groups. The OPH and the VAC will communicate directly with facilities to ensure proper COVID-19 vaccine education, management, prioritization, documentation, and follow- up. As higher volumes of doses become available in Phase 2, administration of vaccine to priority groups will continue to occur through registered vaccine providers in the state immunization registry LINKS, such as hospitals, pharmacies and healthcare providers. Vaccine will be distributed to the public through multiple mechanisms, including a combination of public and private providers. In Phase 3, when a sufficient supply of vaccine is expected, we will expand distribution and vaccinators. Flexibility within this framework is necessary for an effective response which will depend on vaccine indications and priority groups at the time. Prioritizing critical populations involves difficult ethical decisions. Guidelines involving critical populations evolve as information changes. Ethical principles used in the deliberation within the VAC include: Utilitarian Principle; Public Order Principle; Narrow Social Utility; Reciprocity; and Subsidiarity. In Louisiana, most COVID-19 vaccine providers are already registered vaccine providers due to rulemaking in April 2020 that required all vaccinations be reported to LINKS. We will rely first on this base of providers to educate, register, and credential to be COVID-19 vaccinators. Potential new vaccine providers will be recruited to enroll through direct communications by OPH and disseminated through 4 | P a g e STATE OF LOUISIANA COVID-19 VACCINATION PLAYBOOK established communication networks. Interested COVID-19 vaccination providers will be required to complete the CDC Provider Agreement along with the appropriate LINKS enrollment documents. Verification of providers for required credentials will occur through a review process conducted by OPH. Louisiana conducts an annual series of influenza mass vaccination exercises, including drive-through vaccination. This year’s exercise will be conducted following infection control, social